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BOARD OF PHARMACY

 

DIVISION 6
DEFINITIONS

855-006-0005
Definitions
As used in OAR chapter 855:
(1) “Board” means
the Oregon Board of Pharmacy unless otherwise specified or required by the context.
(2) "Certified Pharmacy Technician"
means a person licensed by the State Board of Pharmacy who assists the pharmacist
in the practice of pharmacy pursuant to rules of the Board and has completed the
specialized education program pursuant to OAR 855-025-0005. Persons used solely
for clerical duties, such as recordkeeping, cashiering, bookkeeping and delivery
of medications released by the pharmacist are not considered pharmacy technicians.
(3) "Collaborative Drug Therapy
Management" means the participation by a pharmacist in the management of drug therapy
pursuant to a written protocol that includes information specific to the dosage,
frequency, duration and route of administration of the drug, authorized by a practitioner
and initiated upon a prescription order for an individual patient and:
(a) Is agreed to by one pharmacist
and one practitioner; or
(b) Is agreed
to by one or more pharmacists at a single pharmacy registered by the board and one
or more practitioners in a single organized medical group, such as a hospital medical
staff, clinic or group practice, including but not limited to organized medical
groups using a pharmacy and therapeutics committee.
(4) "Compounding" means the preparation,
mixing, assembling, packaging, or labeling of a drug or device:
(a) As the result of a practitioner’s
prescription drug order, or initiative based on the relationship between the practitioner,
the pharmacist and the patient, in the course of professional practice; or
(b) For the purpose of, or as
an incident to, research, teaching, or chemical analysis and not for sale or dispensing;
or
(c) The preparation of drugs
or devices in anticipation of prescription drug orders based on routine, regularly
observed prescribing patterns; or
(d) As a component of a Shared
Pharmacy Service agreement as defined in section (21) of this rule.
(5) "Confidential Information"
means any patient information obtained by a pharmacist or pharmacy.
(6) "Consulting Pharmacist"
means a pharmacist that provides a consulting service regarding a patient medication,
therapy management, drug storage and management, security, education, or any other
pharmaceutical service.
(7) The "Container" is the device
that holds the drug and that is or may be in direct contact with the drug.
(8) "Dispensing or Dispense"
means the preparation and delivery of a prescription drug pursuant to a lawful order
of a practitioner in a suitable container appropriately labeled for subsequent administration
to or use by a patient or other individual entitled to receive the prescription
drug.
(9) "Interpretation and evaluation
of prescription orders" means the review of the order for therapeutic and legal
correctness. Therapeutic review includes identification of the prescription drug
ordered, its applicability and its relationship to the other known medications used
by the patient and determination of whether or not the dose and time interval of
administration are within accepted limits of safety. The legal review for correctness
of the prescription order includes a determination that the order is valid and has
not been altered, is not a forgery, is prescribed for a legitimate medical purpose,
contains all information required by federal and state law, and is within the practitioner's
scope of practice.
(10) "Labeling" means the process
of preparing and affixing of a label to any drug container exclusive, however, of
the labeling by a manufacturer, packer or distributor of anon-prescription drug
or commercially packaged legend drug or device.
(11) "Monitoring of therapeutic
response or adverse effect of drug therapy" means the follow up of the therapeutic
or adverse effect of medication upon a patient, including direct consultation with
the patient or his agent and review of patient records, as to result and side effect,
and the analysis of possible interactions with other medications that may be in
the medication regimen of the patient. This section shall not be construed to prohibit
monitoring by practitioners or their agents.
(12) "Medication Therapy Management
(MTM)" means a distinct service or group of services that is intended to optimize
therapeutic outcomes for individual patients. Medication Therapy Management services
are independent of, but can occur in conjunction with, the provision of a medication
product.
(13) "Nationally Certified Exam"
means an exam that is approved by the Board which demonstrates successful completion
of a Specialized Education Program. The exam must be reliable, psychometrically
sound, legally defensible and valid.
(14) "Non-legend drug" means
a drug which does not require dispensing by prescription and which is not restricted
to use by practitioners only.
(15) "Offering or performing
of those acts, services, operations or transactions necessary in the conduct, operation,
management and control of pharmacy" means, among other things:
(a) The creation and retention
of accurate and complete patient records;
(b) Assuming authority and responsibility
for product selection of drugs and devices;
(c) Developing and maintaining
a safe practice setting for the pharmacist, for pharmacy staff and for the general
public;
(d) Maintaining confidentiality
of patient information.
(16) "Oral Counseling" means
an oral communication process between a pharmacist and a patient or a patient’s
agent in which the pharmacist obtains information from the patient (or agent) and
the patient's pharmacy records, assesses that information and provides the patient
(or agent) with professional advice regarding the safe and effective use of the
prescription drug for the purpose of assuring therapeutic appropriateness.
(17) Participation in Drug Selection
and Drug Utilization Review:
(a) "Participation in drug selection"
means the consultation with the practitioner in the selection of the best possible
drug for a particular patient.
(b) "Drug utilization review"
means evaluating prescription drug order in light of the information currently provided
to the pharmacist by the patient or the patient's agent and in light of the information
contained in the patient's record for the purpose of promoting therapeutic appropriateness
by identifying potential problems and consulting with the prescriber, when appropriate.
Problems subject to identification during drug utilization review include, but are
not limited to:
(A) Over-utilization or under-utilization;
(B) Therapeutic duplication;
(C) Drug-disease contraindications;
(D) Drug-drug interactions;
(E) Incorrect drug dosage;
(F) Incorrect duration of treatment;
(G) Drug-allergy interactions;
and
(H) Clinical drug abuse or misuse.
(18) "Pharmaceutical Care" means
the responsible provision of drug therapy for the purpose of achieving definite
outcomes that improve a patient's quality of life. These outcomes include:
(a) Cure of a disease;
(b) Elimination or reduction
of a patient's symptomatology;
(c) Arrest or slowing of a disease
process; or
(d) Prevention of a disease
or symptomatology.
(19) "Pharmacy Technician" means
a person licensed by the State Board of Pharmacy who assists the pharmacist in the
practice of pharmacy pursuant to rules of the Board but has not completed the specialized
education program pursuant to OAR855-025-0010.
(20) "Prescription released
by the pharmacist” means, a prescription which has been reviewed by the pharmacist
that does not require further pharmacist intervention such as reconstitution or
counseling.
(21) “Prohibited conduct”
means conduct by a licensee that:
(a) Constitutes a criminal act
against a patient or client; or
(b) Constitutes a criminal act
that creates a risk of harm to a patient or client.
(22) "Proper and safe storage
of drugs and devices and maintenance of proper records therefore" means housing
drugs and devices under conditions and circumstances that:
(a) Assure retention of their
purity and potency;
(b) Avoid confusion due to similarity
of appearance, packaging, labeling or for any other reason;
(c) Assure security and minimize
the risk of their loss through accident or theft;
(d) Accurately account for and
record their receipt, retention, dispensing, distribution or destruction;
(e) Protect the health, safety
and welfare of the pharmacist, pharmacy staff and the general public from harmful
exposure to hazardous substances.
(23) "Responsibility for advising,
when necessary or when regulated, of therapeutic values, content, hazards and use
of drugs and devices" means advice directly to the patient, either verbally or in
writing as required by these rules or federal regulation, of the possible therapeutic
response to the medication, the names of the chemicals in the
medication, the possible side effects of major importance, and the methods of use
or administration of a medication.
(24) "Shared Pharmacy Service" means a
written agreement, that has been approved in writing by the board, that exists for
the processing by a pharmacy of a request from another pharmacy or a practitioner
licensed to prescribe the drug, to fill or refill a prescription or a drug order,
or to perform processing functions including but not limited to:
(a) Dispensing;
(b) Drug utilization review;
(c) Claims adjudication;
(d) Refill authorizations;
(e) Compounding; and
(f) Therapeutic interventions.
(25) "Specialized Education
Program" means;
(a) A program providing education
for persons desiring licensure as pharmacy technicians that is approved by the board
and offered by an accredited college or university that grants a two-year degree
upon successful completion of the program; or
(b) A structured program approved
by the board and designed to educate pharmacy technicians in one or more specific
issues of patient health and safety that is offered by:
(A) An organization recognized
by the board as representing pharmacists or pharmacy technicians;
(B) An employer recognized by
the board as representing pharmacists or pharmacy technicians; or
(C) A trade association recognized
by the board as representing pharmacies.
(26) "Supervision by a pharmacist"
means being stationed within the same work area as the pharmacy technician or certified
pharmacy technician being supervised, coupled with the ability to control and be
responsible for the pharmacy technician or certified pharmacy technician's action.
(27) "Therapeutic substitution"
means the act of dispensing a drug product with a different chemical structure for
the drug product prescribed under circumstances where the prescriber has not given
clear and conscious direction for substitution of the particular drug for the one
which may later be ordered.
(28) "Unprofessional conduct"
means conduct unbecoming a licensee or detrimental to the best interests of the
public, including conduct contrary to recognized standards of ethics of pharmacy
or conduct that endangers the health, safety or welfare of a patient or client.
Unprofessional conduct includes but is not limited to:
(a) Fraud or misrepresentation
in dealings relating to pharmacy practice with:
(A) Customers, patients or the
public;
(B) Practitioners authorized
to prescribe drugs, medications or devices;
(C) Insurance companies;
(D) Wholesalers, manufactures
or distributors of drugs, medications or devices;
(E) Health care facilities;
(F) Government agencies; or
(G) Drug outlets.
(b) Illegal use of drugs, medications
or devices without a practitioner's prescription, or otherwise contrary to federal
or state law or regulation;
(c) Any use of intoxicants,
drugs or controlled substances that endangers or could endanger the licensee or
others;
(d) Theft of drugs, medications
or devices, or theft of any other property or services under circumstances which
bear a demonstrable relationship to the practice of pharmacy;
(e) Dispensing a drug, medication
or device where the pharmacist knows or should know due to the apparent circumstances
that the purported prescription is bogus or that the prescription is issued for
other than a legitimate medical purpose, including circumstances such as:
(A) Type of drug prescribed;
(B) Amount prescribed; or
(C) When prescribed out of context
of dose.
(f) Any act or practice relating
to the practice of pharmacy that is prohibited by state or federal law or regulation;
(g) The disclosure of confidential
information in violation of Board rule;
(h) Engaging in collaborative
drug therapy management in violation of ORS Chapter 689 and the rules of the Board;
(i) Authorizing or permitting
any person to practice pharmacy in violation of the Oregon Pharmacy Act or the rules
of the Board;
(j) Any conduct or practice
by a licensee or registrant which the Board determines is contrary to accepted standards
of practice; or
(k) Failure to cooperate with
the Board pursuant to OAR 855-001-0035.
(29) "Verification" means the
confirmation by the pharmacist of the correctness, exactness, accuracy and completeness
of the acts, tasks, or functions performed by an intern or a pharmacy technician
or a certified pharmacy technician.
Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.151,
689.155, 689.305, 689.405 & 689.455

Hist.: 1PB 2-1979(Temp), f.
& ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; 1PB 3-1984, f. & ef. 4-16-84;
PB 2-1988, f. & cert. ef. 5-3-88; PB 2-1989, f. & cert. ef. 1-30-89; PB
4-1992, f. & cert. ef. 8-25-92; PB 1-1994, f. & cert. ef. 2-2-94; BP 4-1998,
f. & cert. ef. 8-14-98; BP 1-2006, f. & cert. ef. 6-9-06; BP 12-2006, f.
& cert. ef. 12-19-06; BP 2-2008, f. & cert. ef. 2-20-08; BP 6-2010, f. &
cert. ef. 6-29-10; BP 3-2012, f. & cert. ef. 6-19-12
855-006-0015
Additional Definitions
(1) Electronically Transmitted Prescription:
(a) Where used in this chapter, Electronically Transmitted Prescription (ETP) means a prescription for a drug or medical device issued by a practitioner, who is licensed and authorized to prescribe pursuant to the laws of this state and is acting within the scope of his or her practice, which has been transmitted by an electronic means that may include but is not limited to:
(A) Transmission by facsimile or hand held digital electronic device to a computer or facsimile;
(B) Transmission from a computer to another computer;
(C) Transmission by facsimile to computer; or
(D) Transmission from a computer to facsimile.
(b) ETP does not include an oral prescription that has been reduced to writing by a pharmacist pursuant to OAR 855-041-0085 and does not include prescriptions, or drug or device orders written for inpatient use in a hospital.
(c) For an ETP to be valid, it must contain the name and immediate contact information of the prescriber, and be electronically encrypted or in some manner protected by up-to-date technology from unauthorized access, alteration or use.
(2) Tamper-resistant Prescription:
(a) Where used in this chapter, Tamper-resistant Prescription means a form for the purpose of issuing a hand written or typed prescription, intended to be manually delivered to a pharmacy, which has been developed, produced and formatted to ensure security, integrity and authenticity using currently accepted technologies.
(b) Formatted features may include but are not limited to characteristics such as:
(A) The word "void" appears when photocopies are attempted;
(B) Background ink which reveals attempted alterations;
(C) Heat sensitive ink that changes colors;
(D) Penetrating ink to prevent chemical alterations;
(E) A watermark which cannot be photocopied;
(F) Coin reactive ink that reveals word when rubbed with a coin;
(G) Sequential numbering.
Stat. Auth.: 689.205

Stats. Implemented: ORS 689.155

Hist.: BP 2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08; BP 1-2008, f. & cert. ef. 2-5-08

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